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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210347

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NDA 210347 describes PIROXICAM, which is a drug marketed by Breckenridge, Cycle, Egis, Flamingo Pharms, Hikma, Ivax Sub Teva Pharms, Micro Labs, Mylan, Pharmobedient, SCS, Solis Pharms, Strides Pharma, Sun Pharm Industries, Teva, Teva Pharms, Unichem, Watson Labs, and Zydus Lifesciences, and is included in twenty-two NDAs. It is available from ten suppliers. Additional details are available on the PIROXICAM profile page.

The generic ingredient in PIROXICAM is piroxicam. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the piroxicam profile page.

Summary for 210347

Tradename:	PIROXICAM
Applicant:	Strides Pharma
Ingredient:	piroxicam
Patents:	0

Pharmacology for NDA: 210347

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 210347

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 210347

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PIROXICAM	piroxicam	CAPSULE;ORAL	210347	ANDA	AvKARE	42291-953	42291-953-01	100 CAPSULE in 1 BOTTLE (42291-953-01)
PIROXICAM	piroxicam	CAPSULE;ORAL	210347	ANDA	AvKARE	42291-954	42291-954-01	100 CAPSULE in 1 BOTTLE (42291-954-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Jan 26, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	20MG
Approval Date:	Jan 26, 2018	TE:	AB	RLD:	No

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